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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Infusion, Intravascular, Electronic
510(k) Number K822891
Device Name FLO CONTROL
Applicant
Dna Medical, Inc.
UT 
Correspondent
Dna Medical, Inc.
UT 
Regulation Number880.5725
Classification Product Code
LDR  
Date Received09/28/1982
Decision Date 11/24/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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